ASH: Continuous Tx Yields Better Results in Multiple Myeloma

by Michael Smith Michael Smith North American Correspondent, MedPage Today
December 14, 2011

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Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

A recent study indicated that maintenance therapy with lenalidomide (Revlimid) should be the standard of care for older patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplant.

Lenalidomide maintenance was generally well tolerated, with no evidence of cumulative toxicities, and only 5% of patients dropped out because of adverse events.

SAN DIEGO -- Maintenance therapy with lenalidomide (Revlimid) should be the standard of care for older patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplant, a researcher said here.

"What is really changing today in the treatment paradigm of myeloma is the concept of continuous treatment," according to Antonio Palumbo, MD, of the University of Torino in Italy.

The field is moving away from a "fixed length of treatment," Palumbo said in an oral session at the annual meeting of the American Society of Hematology.

The MM-15 trial provides additional backing for that movement, Palumbo said, especially in older patients not eligible for a transplant.

The study enrolled 459 patients with newly diagnosed disease from 82 centers in Europe, Australia, and Israel. They were randomly assigned to eight 28-day cycles of melphalan (Alkeran) and prednisone; both of those drugs plus lenalidomide (Revlimid); or all three drugs followed by maintenance therapy with lenalidomide.

The median age of the patients was 71, and about 75% in each arm were between 65 and 75 and formed a prespecified focus of the study, Palumbo reported.

Interim analyses have shown promising efficacy results for the maintenance arm, he said, but the data are now complete for progression-free survival and continue to show a benefit.

Specifically, for all patients, the maintenance arm delivered significantly better progression-free survival: 31 months compared with 14 months for the three-drug combination and 13 months for melphalan and prednisone.

Comparing the maintenance arm with the three-drug arm, the hazard ratio was 0.34 (P<0.001). This benefit was seen in all subgroups, including patients 65 to 75.

However, there is no significant difference in overall survival yet.

Lenalidomide maintenance was generally well tolerated, with no evidence of cumulative toxicities, and only 5% of patients dropped out because of adverse events, Palumbo said.

There were more second primary cancers in the maintenance (12) and three-drug arms (10) compared with the melphalan/prednisone arm (four), but the rate was less than 5% in any arm, Palumbo said.

In contrast, the risk of disease progression or death from myeloma was 10 to 15 times higher in all arms than the risk of a second cancer, he said.

He argued that the results of the trial suggest that maintenance should be standard treatment in patients not eligible for a transplant.

The study "provided a demonstration of the importance of a maintenance phase after an induction," commented Michele Cavo, MD, of the Bologna University School of Medicine in Italy, who was not part of the study but who helped moderate the ASH session.

"It echoes the results we have so far obtained in the transplant setting," in which multiple phases of therapy are standard, he told MedPage Today.

"The future treatment paradigm for multiple myeloma patients -- both transplant-eligible and non-transplant-eligible -- will have an induction phase followed by maintenance," he said. Those receiving transplants also will undergo a consolidation phase, he added.

The study was supported by Celgene. Palumbo reported financial links with the company.

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